Musical Intervention and Physiological Stress and Inflammatory Biomarkers in Mechanically Ventilated ICU Patients

NCT06120660 | Completed Results

• 2 other identifiers: 2022.537Investiga SEEIUC 2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial evaluates the effects of a musical intervention on hormonal and inflammatory biomarkers in sedated adult patients undergoing invasive mechanical ventilation in an intensive care unit. Serum cortisol, prolactin, and interleukin-6 levels are measured before and after the intervention, together with hemodynamic parameters. The aim is to assess whether music modulates physiological stress and inflammatory responses in critically ill patients

Conditions

Sedation; Critical Illness; Respiration, Artificial; Inflammation; Stress, Physiological

Keywords

music therapy; critical care; stress, psychological; respiration, artificial; sedation; inflammation

Outcome Measures

Primary Outcomes (3)

• Levels of Serum Cortisol

  Serum cortisol levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the music intervention or standard care using standard laboratory assays. This measure reflects the acute physiological stress response.

  Only one intervention per person will be performed. Serum levels will be measured before and after the intervention (minute 0 and 60).

• Levels of Prolactin

  Serum prolactin levels were measured from venous blood samples obtained immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. This biomarker reflects neuroendocrine stress response and can indicate changes related to the music intervention.

  Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.

• Levels of Interleukin 6

  Serum interleukin-6 (IL-6) levels were measured from venous blood samples collected immediately before (minute 0) and after (minute 60) the intervention using standard laboratory immunoassays. IL-6 is a pro-inflammatory cytokine and its serum concentration reflects acute systemic inflammatory activity.

  Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.

Secondary Outcomes (8)

• Bispectral Index (BIS)

  BIS values will be measured immediately before and after the intervention (minute 0 and 60).

• Systolic Blood Pressure

  Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

• Diastolic Blood Pressure

  Blood pressure was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

• Heart Rate

  Heart rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

• Respiratory Rate

  Respiratory rate was measured before (minute 0) and after (minute 60) the intervention. Although values were recorded every 10 minutes, only baseline and final measurements are reported.

Study Arms (2)

Music Intervention

EXPERIMENTAL

Participants assigned to this arm receive a structured music therapy session delivered through headphones in addition to usual ICU care.

Other: Music Therapy

Standard Care (Control)

NO INTERVENTION

Participants assigned to this arm receive usual ICU care without any additional auditory intervention.

Interventions

Music Therapy OTHER

A 60-minute session of relaxing, slow-tempo recorded music (60-80 bpm) delivered through over-ear headphones. The intervention is administered once, while the patient remains sedated and mechanically ventilated. Volume and audio equipment are adjusted according to ICU safety protocols.

Music Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years. Admitted to the intensive care unit (ICU) for at least 24 hours. Intubated and undergoing invasive mechanical ventilation. Presence of an arterial catheter and/or central venous catheter. Sedation level corresponding to BIS 40-60. Absence of pain at baseline and during the intervention, defined as a CPOT score = 0 (Critical-Care Pain Observation Tool).
• No previous exposure to music therapy or other musical interventions during the current hospital stay.

You may not qualify if:

• Severe neurological disease or injury, including encephalitis, diffuse axonal injury, or other central nervous system pathologies.
• Severe psychiatric illness. Suspected or confirmed drug or alcohol intoxication, overdose, withdrawal, or abstinence syndrome.
• Hearing impairment that would limit perception of the music intervention. Cranial or skull lesions preventing safe placement of headphones. Limitation of therapeutic effort or expected death within the next 24 hours. Diagnosis of brain death. Inability to obtain informed consent from the legal representative within 72 hours of ICU admission.
• Refusal by the responsible attending physician.

Sponsors & Collaborators

• University of Oviedo: lead
• Sociedad Española de Enfermería Intensiva y Unidades Coronarias: collaborator

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Related Publications (8)

• Erdogan Z, Atik D. Complementary Health Approaches Used in the Intensive Care Unit. Holist Nurs Pract. 2017 Sep/Oct;31(5):325-342. doi: 10.1097/HNP.0000000000000227.

  PMID: 28786890 BACKGROUND

• Umbrello M, Sorrenti T, Mistraletti G, Formenti P, Chiumello D, Terzoni S. Music therapy reduces stress and anxiety in critically ill patients: a systematic review of randomized clinical trials. Minerva Anestesiol. 2019 Aug;85(8):886-898. doi: 10.23736/S0375-9393.19.13526-2. Epub 2019 Apr 3.

  PMID: 30947484 BACKGROUND

• Thaut MH. Music as therapy in early history. Prog Brain Res. 2015;217:143-58. doi: 10.1016/bs.pbr.2014.11.025. Epub 2015 Jan 31.

  PMID: 25725914 BACKGROUND

• Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD 3rd, Khan S, Heiderscheit A, Chlan LL, Khan B. Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial. Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.

  PMID: 35854358 BACKGROUND

• Kakar E, Billar RJ, van Rosmalen J, Klimek M, Takkenberg JJM, Jeekel J. Music intervention to relieve anxiety and pain in adults undergoing cardiac surgery: a systematic review and meta-analysis. Open Heart. 2021 Jan;8(1):e001474. doi: 10.1136/openhrt-2020-001474.

  PMID: 33495383 BACKGROUND

• Khan SH, Wang S, Harrawood A, Martinez S, Heiderscheit A, Chlan L, Perkins AJ, Tu W, Boustani M, Khan B. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial. Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.

  PMID: 29187230 BACKGROUND

• Khan SH, Kitsis M, Golovyan D, Wang S, Chlan LL, Boustani M, Khan BA. Effects of music intervention on inflammatory markers in critically ill and post-operative patients: A systematic review of the literature. Heart Lung. 2018 Sep-Oct;47(5):489-496. doi: 10.1016/j.hrtlng.2018.05.015. Epub 2018 Jul 9.

  PMID: 30001799 BACKGROUND

• Taets GGC, Jomar RT, Abreu AMM, Capella MAM. Effect of music therapy on stress in chemically dependent people: a quasi-experimental study. Rev Lat Am Enfermagem. 2019 Jan 17;27:e3115. doi: 10.1590/1518-8345.2456.3115.

  PMID: 30698217 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Respiratory Aspiration; Inflammation; Stress, Psychological

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

This single-center study was conducted in the complex ICU environment, where multiple confounders may influence physiological responses. The inclusion of sedated patients and the use of a single standardized music piece limit generalizability to other populations and personalized music approaches.

Results Point of Contact

• Title: Alba Maestro-González
• Organization: Universidad de Oviedo

maestroalba@uniovi.es

+34 985 10 35 41

Study Officials

• Alba Maestro-González, Ph.D.

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients were blinded due to continuous sedation throughout the intervention period. Bedside healthcare professionals responsible for routine care, sedation, and hemodynamic monitoring were also unaware of group allocation. Laboratory personnel analyzing biomarker samples were blinded to treatment assignment. The investigator placing the headphones was not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel design comparing a musical intervention plus usual care versus usual care alone in mechanically ventilated ICU patients.

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: November 7, 2023
• Study Start: October 14, 2023
• Primary Completion: June 28, 2025
• Study Completion: January 27, 2026
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)